Exercise Trial in Chronic Kidney Disease (AWARD)

January 3, 2023 updated by: Stephen Seliger, University of Maryland, Baltimore

Randomized Trial of Aerobic Exercise Training on Cognitive and Physical Function in Chronic Kidney Disease

Chronic Kidney Disease (CKD) is exceedingly common in older adults, in whom it is associated with impairment in cognition and physical function. The purpose of this study is to test the effects of 12 months of aerobic and resistance exercise training compared to health education on cognitive and physical performance in 120 older adults with CKD not requiring dialysis. The results of this study will be essential for demonstrating the effectiveness of exercise in improving function and ultimately preventing disability in this high-risk population of older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a parallel-group randomized controlled trial comparing 12 months of aerobic and resistance exercise training vs. health education (attention control) on neurocognitive and physical performance among community-dwelling older adults (age >55) and CKD stage 3b and 4. Co-primary outcomes are change in physical performance (including aerobic capacity and submaximal walking) and neurocogntive performance (including executive functions).

Outcome measures will be assessed at baseline and after 6- and 12 months. Exercise training will occur thrice weekly at a dedicated research exercise center and will be supervised by exercise specialists.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Baltimore VA Medical Center / University of Maryland Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stage 3-4 Chronic kidney disease (estimated Glomerular Filtration Rate 15-45)
  • Age 60 to 85
  • English Speaking

Exclusion Criteria:

  • Dementia or cognitive impairment
  • Renal transplant
  • New York Heart Association class 3-4 heart failure
  • Severe Chronic Lung Disease
  • Unstable angina or coronary revascularization within the last 3 months
  • Orthopedic problems that would preclude aerobic exercise training
  • Known, untreated infection
  • Disabling arthritis
  • Uncontrolled arrhythmia
  • More than 14 alcoholic drinks per week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerobic exercise
12 months of treadmill walking and strength training exercise. Exercise is gradually progressed in walking speed and time on the treadmill based on the individual's tolerance, abilities, and safety. For months 1-6 exercise will take place 3 times per week at the research center. For months 6-12 exercise will take place 2 times per week at the center and 1 time per week at home.
Behavioral: Aerobic exercise training
12 months of aerobic exercise
Active Comparator: Health Education
12 months of Health education sessions which will cover topics important to older adults (safe travel, age-appropriate preventative screenings, resources for reliable health information, and topics relevant to chronic kidney disease). For months 1-6 classes will take place 1 time per week. For months 6-12 classes will take place 1 time per month.
Behavioral: Health Education
12 months of health education sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Peak Aerobic Capacity
Time Frame: Baseline, 6 months, 12 months
VO2peak, measured by Graded Exercise Treadmill Test (GXT) with a modified Balke protocol - higher indicates better aerobic capacity
Baseline, 6 months, 12 months
Change in 6 Minute Walk
Time Frame: Baseline, 6 months, 12 months
Distance walked in 6 minutes - greater distance represents higher function
Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Physical Function
Time Frame: Baseline, 6 months, 12 months
Timed Up and Go Test
Baseline, 6 months, 12 months
Number With Short Physical Performance Battery (SPPB) Score <10 (Out of 12 Maximum)
Time Frame: Baseline, 6 months, 12 months
Short Physical Performance Battery is a test of lower extremity function designed to be administered in older adults, consisting of three components: 1) usual gait speed over a 4-meter course; 2) five repeated chair stands; 3) standing balance battery. Each component is scored 0-4, with higher scores indicating better function, and the total scores of each component are summed (range, 0-12).
Baseline, 6 months, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

October 31, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

October 26, 2011

First Posted (Estimate)

October 28, 2011

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00045276
  • 1R01DK090401-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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